Page 105 - Practical Technology 2025

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Clinical Pharmacy-Pharm D Level Three 2 Semester 2024/2025 Pharmaceutical Technology (PT 607)

• Disintegration time:

According to USP ------- 5 – 30 min.
According to BP -------- 5 – 15 min.

➢ If 1 or 2 tablets fail the test, repeat the test on 12 additional tablets, not fewer than
16 of total of 18 tested tablets disintegrate completely.

➢ If more than 2 tablets fail the test, the batch is rejected.

• Concentration = (Abs/Slope) х Dilution Factor (DF)

• Amount of drug dissolved = (Abs/Slope) х DF х Volume of dissolution medium

• % Drug Dissolved = (Amount dissolved / drug content) х 100

Example 1:

Carry out the quality control tests for the following batch of tablets according to the

following values and indicate if it’s accepted or rejected:

Tab Diameter Thickness Weight Friability
No. (mm) (mm) (mg) Wt. before Wt. after
1 11.5 4.53 200
2 11.6 4.47 190
3 12 4.48 205
4 12.2 4.55 204
5 12 4.59 195
6 12 4.55 193
7 11.9 4.55 210
8 11.8 4.52 182

9 12.1 4.53 194
10 11.2 4.50 198 7.4318 gm 7.4082 gm
11 11.8 4.55 201
12 12 4.52 201
13 12.1 4.50 200
14 12.1 4.49 203
15 11.7 4.49 208
16 11.6 4.47 209
17 11.6 4.53 180
18 12.1 4.52 204
19 11.4 4.50 192
20 12 4.55 205

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